Spine Wave Inc

FDA Filings

This page includes the latest FDA filings for Spine Wave Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3004638600
FEI Number3004638600
NameSPINE WAVE, INC.
Owner & OperatorSPINE WAVE, INC.
Contact AddressTHREE ENTERPRISE DR. SUITE 210
Shelton CT 06484 US
Official Correspondent
  • RONALD K SMITH
  • x-203-9449494-340
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressTHREE ENTERPRISE DR. SUITE 210
SHELTON, CT 06484 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Repack or Relabel Medical Device



FDA Filings

Device
Company
DeviceDate
Spine Wave, Inc.
Salvo® Spine System2020-11-05
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-19
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-19
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-15
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-15
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-14
Spine Wave, Inc.
Leva® Anterior Interbody System 2020-05-14
Spine Wave, Inc.
Tornado™ 2020-04-23
Spine Wave, Inc.
Tornado™ 2020-04-23
Spine Wave, Inc.
Tornado™ 2020-04-23
Spine Wave, Inc.
Tornado™ 2020-04-23
Spine Wave, Inc.
Tornado™ 2020-04-23
Spine Wave, Inc.
CapSure® Spine System 11-37612020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37562020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37512020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37462020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37412020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37362020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-37312020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36562020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36512020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36462020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36412020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36362020-04-20
Spine Wave, Inc.
CapSure® Spine System 11-36312020-04-20
Spine Wave, Inc.
Accent® Cervical Spacer System 15-60082020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-60072020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-60062020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-60052020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46122020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46112020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46102020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46092020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46082020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46072020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46062020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-46052020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40122020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40112020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40102020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40092020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40082020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40072020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40062020-02-24
Spine Wave, Inc.
Accent® Cervical Spacer System 15-40052020-02-24
Spine Wave, Inc.
Leva® Spacer System 11-70252020-02-24
Spine Wave, Inc.
Leva® Spacer System 11-70242020-02-24
Spine Wave, Inc.
Leva® Spacer System 11-70232020-02-24
Spine Wave, Inc.
Leva® Spacer System 11-70222020-02-24
Spine Wave, Inc.
StaXx® XDL System 11-14632020-02-24
Spine Wave, Inc.
StaXx® XDL System 11-14602020-02-24
Spine Wave, Inc.
StaXx® XDL System 11-14532020-02-24
Spine Wave, Inc.
StaXx® XDL System 11-14502020-02-24
Spine Wave, Inc.
StaXx® XD System 11-17512020-02-24
Spine Wave, Inc.
StaXx® XD System 11-17502020-02-24
Spine Wave, Inc.
StaXx® XD System 11-16252020-02-24
Spine Wave, Inc.
StaXx® XD System 11-16222020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15512020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15502020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15292020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15252020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15222020-02-24
Spine Wave, Inc.
StaXx® XD System 11-13262020-02-24
Spine Wave, Inc.
StaXx® XD System 11-13232020-02-24
Spine Wave, Inc.
StaXx® XD System 11-11952020-02-24
Spine Wave, Inc.
StaXx® XD System 11-11922020-02-24
Spine Wave, Inc.
StaXx® XD System 11-11792020-02-24
Spine Wave, Inc.
StaXx® XD System 11-11752020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-72142020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-72132020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-72122020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-72112020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-72102020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73142020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73132020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73122020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73112020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73102020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73092020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73082020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-73072020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71142020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71132020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71122020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71112020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71102020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15812020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15802020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15912020-02-24
Spine Wave, Inc.
StaXx® XD System 11-15902020-02-24
Spine Wave, Inc.
StaXx® XD System 11-16692020-02-24
Spine Wave, Inc.
StaXx® XD System 11-16662020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71092020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71082020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-71072020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70152020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70142020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70132020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70122020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70112020-02-24
Spine Wave, Inc.
Leva™ Spacer System 11-70102020-02-24
Spine Wave, Inc.
Spine Wave Navigated Instruments2019-10-10
SPINE WAVE, INC.
Salvo Spine System2019-08-02
Spine Wave, Inc.
Salvo™ Spine System2019-07-10
SPINE WAVE, INC.
Salvo Spine System2019-01-02
Spine Wave, Inc.
Salvo™ Spine System2018-12-12
SPINE WAVE, INC.
Spine Wave Navigated Instruments2018-11-07
Spine Wave, Inc.
Spine Wave Navigated Instruments2018-10-24
SPINE WAVE, INC.
Proficient Posterior Cervical Spine System2018-08-15
Spine Wave, Inc.
Proficient® Posterior Cervical Spine System2018-07-30
SPINE WAVE, INC.
Scalpel Handle2018-06-21
SPINE WAVE, INC.
Paramount? Anterior Cervical Spine System2018-06-07
SPINE WAVE, INC.
Proficient? Posterior Cervical Spine System2018-01-02
Spine Wave, Inc.
Proficient® Posterior Cervical Spine System2017-12-15
Spine Wave, Inc.
Paramount Anterior Cervical Cage System2017-11-01
Spine Wave, Inc.
CapSure® PS System2017-08-16
SPINE WAVE, INC.
Leva(R) Anterior Expandable Spacer System2017-04-10
SPINE WAVE, INC.
Leva Anterior Expandable Spacer System2017-04-06
SPINE WAVE, INC.
Paramount? Anterior Cervical Spine System2017-03-02
SPINE WAVE, INC.
Proficient? Posterior Cervical Spine System2017-02-20
SPINE WAVE, INC.
Spine Wave Anterior Cervical Spine System2017-02-16
Spine Wave, Inc.
Proficient™ Posterior Cervical Spine System2017-02-07
SPINE WAVE, INC.
Leva? Anterior Interbody System2016-11-28
Spine Wave, Inc.
Leva® Anterior Interbody System2016-11-22
SPINE WAVE, INC.
Sniper? Spine System2016-09-25
SPINE WAVE, INC.
Sniper? Spine System2016-09-25
SPINE WAVE, INC.
Leva(R) Spacer System2016-04-18
SPINE WAVE, INC.
Leva Spacer System2016-04-15
SPINE WAVE, INC.
True Position? Pivoting Spacer System2016-03-03
SPINE WAVE, INC.
Sniper (R) Spine System2016-02-26
SPINE WAVE, INC.
Velocity? Expandable Interbody System2016-02-03
SPINE WAVE, INC.
Spine Wave Gen II Expandable Interbody System2016-01-15
SPINE WAVE, INC.
Sniper? Spine System2015-11-13
SPINE WAVE, INC.
Sniper? Spine System2015-11-13
SPINE WAVE, INC.
Sniper? Spine System2015-11-13
SPINE WAVE, INC.
Sniper? Spine System2015-11-13
SPINE WAVE, INC.
Leva? Spacer System2015-11-13
SPINE WAVE, INC.
Leva? Spacer System2015-11-13
SPINE WAVE, INC.
StaXx? XD System2015-11-13
SPINE WAVE, INC.
Ni-Lock? Anterior Cervical Plate System2015-10-23
SPINE WAVE, INC.
Accent? Cervical Spacer System2015-10-23
SPINE WAVE, INC.
Sniper Spine System2015-08-31
SPINE WAVE, INC.
Sniper Spine System2015-07-31
SPINE WAVE, INC.
Leva Spacer System2015-07-09
SPINE WAVE, INC.
Leva(TM) Spacer System2015-03-05
SPINE WAVE, INC.
StaXx(R) XD System2015-02-19
SPINE WAVE, INC.
Leva(TM) Spacer System2015-02-13
SPINE WAVE, INC.
LEVA (TM) SPACER SYSTEM2015-01-26
SPINE WAVE, INC.
Proficient (TM) Facet Screw Spine System2015-01-16
SPINE WAVE, INC.
ABACUS (TM) SPACER SYSTEM2014-10-23
SPINE WAVE, INC.
Abacus Spacer System2014-05-13
SPINE WAVE, INC.
ABACUS TM SPACER SYSTEM2014-04-07
SPINE WAVE, INC.
ANNEXTM ADJACENT LEVEL SYSTEM2014-01-10
SPINE WAVE, INC.
STAXX(R) SYSTEM2013-12-06
SPINE WAVE, INC.
STAXX IBL SYSTEM2013-10-04
SPINE WAVE, INC.
STAXX IBL SYSTEM2013-08-20
SPINE WAVE, INC.
CAPSURE PS SYSTEM2013-08-09
SPINE WAVE, INC.
STAXX(R) IB SYSTEM2013-04-11
SPINE WAVE, INC.
CAPSURE(R) PS SYSTEM2012-10-11
SPINE WAVE, INC.
STAXX XD SYSTEM2012-08-29
SPINE WAVE, INC.
CAPSURE(R) PS SYSTEM2012-06-07
SPINE WAVE, INC.
STAXX(R) XD SYSTEM2011-12-13
SPINE WAVE, INC.
CAPSURE(R) PS SYSTEM2011-08-31
SPINE WAVE, INC.
STAXX XDL SYSTEM2011-08-19
SPINE WAVE, INC.
STAXXSD SYSTEM2011-07-19
SPINE WAVE, INC.
StaXx(R) XD System2010-12-15
SPINE WAVE, INC.
RETRACTOR2010-12-15
SPINE WAVE, INC.
STAXX(R) XD SYSTEM2010-11-30
SPINE WAVE, INC.
StaXx(R) XD System2010-09-24
SPINE WAVE, INC.
STAXX XD SYSTEM2010-09-10
SPINE WAVE, INC.
Sniper MIS System2010-07-16
SPINE WAVE, INC.
MIS SYSTEM2010-06-04
SPINE WAVE, INC.
CapSure(R) PS Spine System2010-03-25
SPINE WAVE, INC.
CapSure(R) PS Spine System2010-03-25
SPINE WAVE, INC.
MODIFICATION TO CAPSURE PS SYSTEM2010-02-12
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
CapSure(R) PS System2009-12-07
SPINE WAVE, INC.
STAXX XD SYSTEM2009-09-03
SPINE WAVE, INC.
CAPSURE PS SYSTEM2009-01-13
SPINE WAVE, INC.
CAPSURE(R) PS SYSTEM2008-12-11
SPINE WAVE, INC.
CAPSURE PS (R) SPINE SYSTEM2008-05-12
SPINE WAVE, INC.
Funnels2007-12-03
SPINE WAVE, INC.
FORCEPS2007-09-13
SPINE WAVE, INC.
CAPSURE PS SPINE SYSTEM2007-06-25
SPINE WAVE, INC.
CAPSURE PS SPINE SYSTEM2007-06-25
SPINE WAVE, INC.
SCREWDRIVER2007-06-25
SPINE WAVE, INC.
CAP DRIVER2007-06-25
SPINE WAVE, INC.
ROD BENDER2007-06-25
SPINE WAVE, INC.
TORQUE WRENCH2007-06-25
SPINE WAVE, INC.
SOUNDING PROBE2007-06-25
SPINE WAVE, INC.
PEDICLE PROBE2007-06-25
SPINE WAVE, INC.
BONE TAP2007-06-25
SPINE WAVE, INC.
AWL2007-06-25
SPINE WAVE, INC.
CAPSURE PEDICLE SCREW SYSTEM2007-04-05
SPINE WAVE, INC.
MANUAL SURGICAL INSTRUMENTS2006-07-12
SPINE WAVE, INC.
SPREADER2006-07-12
SPINE WAVE, INC.
DISTRACTOR2006-07-12
SPINE WAVE, INC.
PITUITARY RONGEUR2006-07-12
SPINE WAVE, INC.
BONE RASP2006-07-12
SPINE WAVE, INC.
RING CURETTE2006-07-12
SPINE WAVE, INC.
OSTEOTOME2006-07-12
SPINE WAVE, INC.
NERVE ROOT RETRACTOR2006-07-12
SPINE WAVE, INC.
STAXX XD SYSTEM2006-04-27
SPINE WAVE, INC.
ARTHROSCOPIC INSTRUMENTS; MANUAL SURGICAL INSTRUMENTS2004-07-01
SPINE WAVE, INC.
GUIDE WIRE2004-07-01
SPINE WAVE, INC.
TAMP2004-07-01
SPINE WAVE, INC.
TEMPLATE2004-07-01
SPINE WAVE, INC.
PIN PULLER2004-07-01
SPINE WAVE, INC.
MALLET2004-07-01
SPINE WAVE, INC.
INSTRUMENT CASES2004-07-01
SPINE WAVE, INC.
WAFER SYSTEM2004-06-24

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